Bijan Elahi

Bijan Elahi Email and Phone Number

Award-winning Medical Device Risk Mgmt Author, Professor, and Consultant @ MedTech Safety
Bijan Elahi's Location
Sarasota, Florida, United States, United States
Bijan Elahi's Contact Details
About Bijan Elahi

With over 30 years in medical device risk management, I am committed to advancing safety in MedTech. My career began in aerospace with NASA, working on low-earth orbit spacecraft and developing a foundation in rigorous risk assessment and safety evaluation. This background launched me on a journey to work with companies ranging from MedTech giants to pioneering startups, continuously innovating and setting new benchmarks in risk management.I’ve had the privilege of educating over 10,000 MedTech professionals worldwide, on the latest knowledge and practices in safety risk management. As a Technical Fellow and educator, I serve as an affiliate professor at Drexel University, USA, and lecture at Eindhoven University of Technology in the Netherlands. My book, Safety Risk Management for Medical Devices, is both a university textbook, and foundational resource for professionals in the field.As the founder of MedTechSafety.com, I continue to provide guidance and education on ISO 14971 compliance and risk analysis. My goal is to empower the MedTech community with the tools, frameworks, and confidence to create safer medical devices—turning challenges into opportunities for innovation and improved healthcare safety.Together, we can build a world where technology serves humanity without compromising safety.

Bijan Elahi's Current Company Details
MedTech Safety

Medtech Safety

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Award-winning Medical Device Risk Mgmt Author, Professor, and Consultant
Bijan Elahi Work Experience Details
  • Medtech Safety
    Principal
    Medtech Safety Nov 2018 - Present
    Global thought-leader, educator, advisor, mentor, and author on medical device risk management. Visit www.medtechsafety.com - Offering comprehensive education, and advisory services on medical device risk management. Over 10,000 individuals trained worldwide.
  • Drexel University School Of Biomedical Engineering, Science And Health Systems
    Affiliate Professor
    Drexel University School Of Biomedical Engineering, Science And Health Systems May 2022 - Present
    Philadelphia, Pennsylvania, Us
  • Eindhoven University Of Technology
    University Lecturer
    Eindhoven University Of Technology Mar 2015 - Present
    Eindhoven, Nl
    Offering graduate education on safety risk management to doctoral students in engineering, and also to members of industry. Focus: medical device technology. This course is mandatory for graduation for the students.
  • Delft University Of Technology
    University Lecturer
    Delft University Of Technology Jun 2016 - Present
    Delft, Nl
    Offering graduate education on medical device risk management
  • Eit Health
    Mentor
    Eit Health May 2020 - Present
    Munich, De
    I mentor and educate small startup companies on medical device safety risk management. This is a concerted effort sponsored by EIT Health, a European initiative for the promotion of knowledge and innovation to promote healthier citizens in Europe.I would be happy to mentor medical startup companies in other parts of the world, in order to promote healthier world citizens.
  • Medtronic
    Corp Advisor, Consultant, Educator, Product Safety Risk-Management
    Medtronic Sep 2011 - May 2024
    Minneapolis, Mn, Us
    Medtronic Technical Fellow, and corp. advisor. In this role I teach risk management, offer consulting, and mentor Medtronic R&D engineers in all business units, worldwide. My aim is to elevate knowledge and skills in risk management globally, in order to produce the safest and highest quality products for our patients. Other benefits are: smoother product approvals, faster to market, and reduced costs.Other responsibilities: Technical assessment of companies for acquisition; contribution to corporate policies, and international standards.
  • Baxter Healthcare Corp.
    Lead System-Designer
    Baxter Healthcare Corp. Feb 2007 - Sep 2011
    Deerfield, Illinois, Us
    Technical leadership for the creation of medical devices and disposables, from concept to retirement. Driving the product development process. Mentoring and developing engineers to their maximum potential. Providing technical input for guiding business decisions. Leadership of teams of engineers in multiple locations and multiple countries. Multi-national market sensitivity -- US & North America, Japan, Europe, Emerging Markets.Voice of the Customer: Gather product requirements via multi-diciplinary interactions with doctors, nurses, patients, Marketing, Regulatory. Architect systems with consideration for continuity from past products, extensibility to future products, and diverse market needs. Design systems in collaboration with Mechanical, Electrical, Software, Clinical, Human Factors, Japanese/European sub-system vendors.

Bijan Elahi Skills

Medical Devices R&d Cross Functional Team Leadership Design Control Product Development Fda Validation Six Sigma Root Cause Analysis Biomedical Engineering Quality System Iso 14971 V&v Product Launch Systems Engineering Capa Risk Management Quality Management Engineering Strategy Fmea Research And Development Product Lifecycle Management Requirements Analysis Process Improvement Design For Manufacturing Design Of Experiments System Architecture System Design Dmaic Commercialization Business Process Improvement Verification And Validation Architecting Pacemakers Doors Medical Device Product Development System Of Systems Engineering Technical Management

Bijan Elahi Education Details

  • University Of Washington
    University Of Washington
    Electrical Engineering
  • Iowa State University
    Iowa State University
    Aerospace Engineering

Frequently Asked Questions about Bijan Elahi

What company does Bijan Elahi work for?

Bijan Elahi works for Medtech Safety

What is Bijan Elahi's role at the current company?

Bijan Elahi's current role is Award-winning Medical Device Risk Mgmt Author, Professor, and Consultant.

What is Bijan Elahi's email address?

Bijan Elahi's email address is bi****@****alth.eu

What schools did Bijan Elahi attend?

Bijan Elahi attended University Of Washington, Iowa State University.

What are some of Bijan Elahi's interests?

Bijan Elahi has interest in Teaching, Innovation, Solving Difficult Engineering Problems, Safety Risk Management, New Medical Product Development.

What skills is Bijan Elahi known for?

Bijan Elahi has skills like Medical Devices, R&d, Cross Functional Team Leadership, Design Control, Product Development, Fda, Validation, Six Sigma, Root Cause Analysis, Biomedical Engineering, Quality System, Iso 14971.

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